—#148028

Product

SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device

FDA product code: KNX — Collector, Urine, (And Accessories) For Indwelling Catheter
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Lot Number NGZG1722

Why it was recalled

Labeling problem

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Bard Medical sent an Urgent Medical Device Product Recall letter dated June 29, 2016. The letter identified the product, the problem, and the action to be taken by the customer. The letter requested that customers examine their inventory and quarantine the product. The letter also requested a sub-recall. The letter included a reply form which is to be returned to Bard. Customers were also instructed if product was further distributed they identify customers and notify them at once. Customers with questions should contact the BMD Recall Coordinator at 1-800-793-8110.

Recalling firm

Firm: C.R. Bard, Inc.
Address: 8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

Distribution pattern: Nationwide Distribution to CA, FL, IL, IA, KY, NC, MN, NC, OR, RI, SD, TX, UT, and WA.

Timeline

Recall initiated: 2016-06-29
Terminated: 2017-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148028. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.